Director, Medical Evaluation & Case Processing Oversight

CSL (EMEA); United Kingdom; On-site; GBP 70,000 - 90,000; Full time

Job summary

A global biotherapeutics leader in the United Kingdom seeks an experienced professional in Pharmacovigilance to oversee Case Management processes and ensure compliance with regulatory standards. Candidates should possess a minimum of 10 years of experience in clinical trials and pharmacovigilance, alongside 5 years of leadership experience. The role includes driving departmental planning, leading transformation initiatives, and ensuring high standards in medical evaluations. Join this innovative team and partake in shaping the future of biotherapeutics.

Benefits

Comprehensive health insurance

Flexible working arrangements

Professional development opportunities

Qualifications

• Minimum of 10 years in Clinical Trial and Post-marketing Pharmacovigilance experience.
• 5 years of managerial/leadership experience.
• Global pharmacovigilance database knowledge required.

Responsibilities

• Oversee Medical Evaluator role for ICSR types.
• Drive department-wide planning: resource, budget, org. strategy.
• Lead transformation initiatives like vendor transitions.

Skills

Clinical Trial experience

Pharmacovigilance knowledge

Leadership skills

Regulatory knowledge

Education

BS/BA, RN, Pharmacist, or similar

Job description

Key Responsibilities

Oversight of Case Management Processes activities

• Oversight of Medical Evaluator role which completes medical review of the following ICSR types: All serious cases from all sources; Non‑serious cases from company‑sponsored clinical study (if required); Legal ICSR (serious and non‑serious); Reportable cases of combination products with device issue(s)/malfunction (serious and non‑serious).
• Medical review duties including seriousness, listedness, and causality assessments; event terms and MedDRA coding; narrative for medical accuracy and consistency; need for Quality Investigations; generation of medical follow‑up queries/Targeted Questionnaires.
• Drive department‑wide planning: resource, budget, and org. strategy.
• Own case management dashboards and governance scorecards.
• Prepare for internal and external inspections including coordination of creation of presentations.
• Lead transformation initiatives (e.g., vendor transitions, digital tools).
• Monitor regulatory trends and represent PV case management in global initiatives.
• Coordinate departmental leadership meetings and communication.
• Pilot innovations (e.g., RPA, AI triage, tech integration).
• Align with Clinical, QA, Regulatory, and Safety Science functions.
• Coordinate creation and update of SOPs.
• Retain product and process knowledge.

Skills and Education Required

Minimum of 10 years of Clinical Trial and Post‑marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.

Qualifications and Education Required

BS/BA, RN, Pharmacist, or similar.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well‑being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.